The Assistant Secretary for Technology Policy (ASTP) released the HTI-5 draft rule in December of 2025, and HLN reviewed this rule with a focus on the impact of these changes on the public health community and submitted the following public comment. When reading these comments, it should be noted that ASTP is doing two things together: First they withdrew many of the proposed rules in the HTI-2 NPRM, posted in the Federal Register as a final notice on December 29, 2025 and shortly thereafter they released the HTI-5 draft rule, the impact of these two things therefore has to be considered together, even if we are not commenting specifically on the withdrawal of the HTI-2 NPRM.
The proposed changes seem to be moving the certification program away from further standardization rather than towards it. Any movement away from standards will make interoperability more complicated and more expensive, for vendors who have to develop multiple approaches for different locations, for public health agencies who will have to go back to the old days of herding cats to try to get consistent interfaces, for clinical sites who will have higher obstacles to effectively interoperate. But the question here is whether it is the certification program and Federal regulation of EHRs that is necessary to help ensure this.
One of the things I think public health is actually good at is organizing itself around developing (through SDOs) and adopting (through organizational collaboration, regulation, and legislation) interoperability standards; ASTP/ONC certainly has helped by promulgating standards with tools like the ISA. But we did this long before the CEHRT program – what helped were the incentives offered by the original HITECH Act; the standards themselves were always developed independently. So, while we have perhaps progressed to the point where the cost of EHR certification has exceeded the benefit that would be accomplished naturally even if certification was not in place, why should we interfere with anything that has been so successful at promoting uniform standards across the country?
Focus on FHIR
HLN Supports ASTP’s objective to reduce and remove long-standing functionality-oriented and non-FHIR-based certification criteria from the Certification Program and the emphasis on FHIR is an important step forward. However, Public Health Agencies are not ready for FHIR yet, and only a few Public Health Agencies are currently able to exchange data in FHIR format. Public health agencies might not be ready for several years and it’s critical to retain Clinical Architecture (CDA) and HL7 v2.5.1 standards where these standards have already successfully been adopted (for example, for eCR, ELRs and Immunization messages).
Furthermore, for Public Health Agencies to move towards FHIR, investments and resources specifically to support PHAs adoption of FHIR is needed.
Certification Criteria for Health Information Technology
The proposed rule removes clinical certification for transmission to public health for Cancer Registries § 170.315(f)(4), Electronic Case Reporting (eCR) § 170.315(f)(5), Antimicrobial Use and Resistance Reporting § 170.315(f)(6), and Healthcare surveys § 170.315(f)(7). For all of these changes HLN is concerned that the removal of certifications will not reduce burden but rather create a situation with increased burden on both health IT developers, healthcare organizations and public health agencies as the removal of these standards based transmissions might result in increased variability and capabilities in the EHR systems..
HLN is especially concerned with the proposal to revise the eCR certification to be a functional requirement and to remove the standards-based requirements to eCR transmissions to public health.The adoption of Standard-based eCR reporting have steadily been increasing in the past years, and this standards based reporting has reduced the burden on both public health and healthcare organizations to meet reporting requirements. The removal of this certification criteria, may allow for industry innovation but we fear this will result in fragmented and jurisdiction-specific reporting, as well as possible innovative solutions that public health does not yet have resources to live up to.
Standards and Implementation Specifications for Health Information Technology
HLN is concerned about the adoption of USCDI v.3.1 in the proposed rule. Successive USCDI versions, and even USCDI v3.0 have data elements of significant value to public health. Adoption of USCDI v3.1 would roll back support for key patient demographic data, which are essential to properly assess public health risk and outcomes. HLN recommends that at least USCDI v4 is adhered to in certification, and preferably the most recent published version of USCDI, USCDI v6 is used.
Transport Methods and Other Protocols Certification Criteria
ASTP seems to be maintaining that adoption is so widespread that removing it will not impact what is actually happening “in the field.” While we agree that this is likely the case, this will shift an additional burden to the clinical user to ensure that this capability is included in the software they are using or intend to buy.
Insights Conditions
ASTP proposes to remove “Insights Conditions” reporting for IIS submission and CDS, as well as Bulk FHIR. We do not support this proposed change as the data would provide valuable information about the deployment of these interfaces in real-world settings.
Links to Public Comments from Other Organizations